Trial document




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  DRKS00012405

Trial Description

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Title

Emotional competences of patients with chronic pain in a specialized institution (ECOP)

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Trial Acronym

ECOP

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URL of the Trial

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Brief Summary in Lay Language

This study helps to examine the emotional competences of people with chronic pain more closely. Our concern is to find out how well people with chronic pain attending a pain management programm are able to identify, understand, express, regulate and actively use emotions. In addition, we want to investigate how much influence emotional competences have on the therapy outcome. For that purpose we will use different questionnaires and tests.

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Brief Summary in Scientific Language

Although everyone experiences emotions, the extent to which we are able to identify emotions, to understand them, to express, to regulate and actively use our own emotion varies interpersonally (Mayer et al., 2004, 2008).
Aim of this study is to explore the emotional competences of patients with chronic pain in a specialized institution and its influence on the therapy outcome.
How well do patients with chronic pain compared to the normal population perceive their emotions, name, express, regulate, accept and use them for themselves? How do patients attending an interdisciplinary outpatient treatment evaluate their emotional skills themselves? Would therapists appraise emotional competences similarly? How about the emotional skills of patients being in a specialized institution when those skills are assessed by a performance test? Do emotional competences change in the course of interdisciplinary multimodal pain therapy? In which way do emotional competences of patients in an interdisciplinary multimodal pain therapy influence the treatment success? Do reports of patients and therapists differ in their predictive value for the therapy outcome?
The investigation includes adult patients with chronic, non-tumor-pain (head, back and joint pain), who attend the outpatient interdisciplinary multimodal pain therapy setting of the univerity clinic pain centre Dresden (USC). The treatment consists of a 4-week period for the main treatment and one refresher week after 10 weeks. In addition to medical care, patients go to physiotherapeutic, psychotherapeutic and art therapy groups. Data collection is managed by continuous evaluation of the interdisciplinary multimodal pain therapy of the USC and their influence factors.
This study is an exploratory study with descriptive observational and methodic units.
Primary parameters are the emotional competence and the underlying emotional intelligence. Secondary parameters are therapy outcomes of the interdisciplinary multimodal pain therapy (catastrophization, acceptance, quality of life, depression, anxiety, pain intensity and pain impairment) and the type of assessing emotional competence (self-assessment, external assessment, performance test). By means of questionnaires (Self- and external rating scales of the German emotional-competence- questionnaire - EKF (Rindermann, 2009), self-report instrument for the assessment of emotion-specific regulation skills ERSQ-ES (Ebert et al., 2012), Pain Catastrophizing Scale (PCS, Meyer et al. 2008), Chronic Pain Acceptance questionnaire (German version, CPAQ-D, Nilges et al. 2007), Short Form 12 (Bullinger and Kirchberger, 1998), Depression Anxiety and Stress Scales (DASS; Nilges and Essau, 2015), German version of Chronic Pain Grading Questionnaire - CPGQ (Klasen et al., 2004)) and a performance test (Mayer-Salovey-Caruso emotional intelligence - MSCEIT (Steinmayr et al., 2011)) associated target parameters will be quantified. A priori calculations yield a necessary total sample size of N = 206. From the above sample a subgroup of n = 56 is going to complete the performance test MSCEIT.
Parametric procedure for testing difference hypotheses (variance analyse with measurement repetition) and related hypotheses (regression and correlation) are foreseen depending on quality of data. With an expected average effect size and α level of 5% a power of 90% is planned. In the course of multiple testing, an alpha error accumulation is prevented by a Bonferroni adjustment. The evaluation is done by means of the statistics software IBM SPSS 21.

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Organizational Data

  •   DRKS00012405
  •   2018/01/08
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  •   yes
  •   Approved
  •   EK 469122017, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

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Health Condition or Problem studied

  •   F45.41 -  [generalization F45.4: Persistent somatoform pain disorder]
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Interventions/Observational Groups

  •   All patients within this study will receive a five week long pain treatment in an interdisciplinary multimodal outpatient setting.

    The emotional competence is quantified with the help of the German self-report instrument for the assessment of emotion-specific regulation skills ERSQ-ES (Ebert et al., 2012). The feelings and moods within the past week are explored with 12 items per affective response: (A) "stress/strain”, B) "fear", C) "anger", D) "sadness", E) "depressed mood", F + G) "more burdening feelings" and H) "positive feelings". For every feeling respective competencies were obtained: (a) “perceive”, b) "rename", c) “understanding”, d) “acceptance”, e) "tolerance", f) "emotional self-support", g) „target-related readiness for confrontation” and h) “modification competence”.

    Furthermore emotional competence is assessed by means of the German self- and external rating scales of the Emotional- Competence- Questionnaire EKF (Rindermann, 2009). The average handling time for the self- or external evaluation version is 10 to 20 minutes. The questionnaire consists of four main scales: (1) "recognize their own emotions" (2) "regulation and control of their own feelings”, (3) "detecting emotions in others", (4) "emotional expressivity". A standard sample for the interpretation of the scales is given (self assessment version: N = 638; third-party evaluation version: N = 421).

    The Mayer-Salovey-Caruso-Emotional-Intelligence-Test - MSCEIT (Steinmayr et al., 2011) is applied to survey emotional intelligence. The paper-pencil test lasts approx. 40 minutes. The standardization sample for the MSCEIT consists of N = 3653 subjects. The MSCEIT contains eight subtests. There are a total of 141 multiple choice items. In theory, the procedure is based on the four-facet model of emotional intelligence (Mayer and Salovey, 1997). The test includes for that reason four facets:
    1) “emotion perception”, 2) "use of emotion", 3) "emotion knowledge” and 4) "emotion regulation". The "experience-based emotional intelligence" (emotion perception and usage), the "strategic emotional intelligence" (emotion knowledge and regulation) and the total value of "emotional intelligence" will result in aggregation of the four facets.

    The therapy outcome catastrophization is estimated by the Pain Catastrophizing Scale (PCS, Meyer et al. 2008). The PCS is a self-assessment questionnaire which consists of 13 items and aims to ascertain catastrophizing thoughts and behaviours. The scale contains three subscales: helplessness, magnification, rumination.

    The acceptance of pain will be assessed by means of the Chronic Pain Acceptance Questionnaire (German version, CPAQ-D, Nilges et al. 2007). The self-assessment questionnaire contains 20 items that will identify the handling and evaluation of chronic pain. The items will be merged into two subscales: "activity engagement "and "pain willingness".

    The therapy outcome quality of life will be estimated via the Short Form 12, a 12- item short form of the Short Form-36 (Bullinger and Kirchberger, 1998). The Short Form (12 and 36) health questionnaire is a self assessment tool, to survey the health-related quality of life. The SF-12 consists of two scales: the physical and the mental quality of life. The two sub-scales include 6 items each.

    Depression or anxiety will be determined by the Depression Anxiety and Stress Scales (DASS; Nilges and Essau, 2015) or the psychological diagnosis. The DASS is a set of three self assessment scales, which were designed to investigate the negative emotional states of depression, anxiety and stress. In the context of the short version this is determined by 21 items - 7 items per scale.

    The pain intensity and impairment will be assessed by the German version of the Chronic Pain Levels Questionnaire - GCPS (Klasen et al., 2004).

    The data collection for this study is carried out at three measurement times: the beginning of the outpatient treatment (week 1, T1), the end of the 4-week long outpatient treatment (T2) and the refresher week (14 weeks later, T3).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary parameters are

I. emotional competences
(1) recognize their own emotions (Self - and external rating scales of the Emotional-Competence- Questionnaire - EKF)
(2) recognition of emotions in others (EKF)
(3) Regulation and control of their own feelings (EKF)
(4) emotional expressivity (EKF)

a) constructive attention steering (German self-report instrument for the assessment of emotion-specific regulation skills - ERSQ-ES)
b) clarity (ERSQ-ES)
c) understanding (ERSQ-ES)
d) acceptance (ERSQ-ES)
e) tolerance (ERSQ-ES)
f) Confrontation readiness (ERSQ-ES)
g) Effective self support (ERSQ-ES)
h) Modification outcome (ERSQ-ES)
i) Change-related self efficiency (ERSQ-ES)
j) Modification skills (ERSQ-ES).

Emotional competences will be quantified by self-assessment questionnaires (EKF, ERSQ-ES) at the beginning of the outpatient treatment, the end of the 4- week treatment and after the refresher week. The external assessment of the emotional competences will be investigated after the fourth week of the outpatient treatment.




II.emotional intelligence (subgroup)
Moreover, before starting the outpatient setting treatment the underlying emotional intelligence will be examined (experience-based emotional intelligence, strategic emotional intelligence) within a subgroup by means of a performance test (Mayer-Salovey-Caruso-Emotional-Intelligence-Test - MSCEIT).

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Secondary Outcome

Secondary parameters are

III.) therapy outcomes of the interdisciplinary multimodal pain therapy (assessed when the treatment starts (T1), after 4 weeks (T2) and after the refresher week (T3)):
catastrophization (Pain Catastrophizing Scale (PCS, Meyer et al. 2008)),
acceptance (Chronic Pain Acceptance Questionnaire (German version, CPAQ-D, Nilges et al. 2007)),
quality of life (Short Form 12 (Bullinger and Kirchberger, 1998)),
depression and anxiety (Anxiety and Stress Scales (DASS;Nilges and Essau, 2015),
pain intensity and pain impairment (German version of Chronic Pain Grading Questionnaire - CPGQ (Klasen et al., 2004))

IV.) the method of assessing emotional competence:
self-assessment
external assessment
performance test.

V.) Furtermore, possible interference and accompanying sizes are going to be assessed within the basic documentation before starting pain treatment: sex,
VI.) age,
VII.) level of education,
VIII.) grade of pain chronification.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/01/08
  •   206
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

The investigation includes adult patients with chronic, non-tumor-pain (head, back and joint pain), who attend an out-patient interdisciplinary multimodal pain therapy of the USC Dresden. Prerequisites for treatment are a chronic pain syndrome, the lack of success using uni-modal therapy approaches and associated psychosocial or pain-related impairment in daily life. In spite of this, a sufficient physical performance for the treatment must be given.

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Exclusion Criteria

Exclusion criteria are cancer-related pain, an age under 18 years, acute organic findings (e.g. serious cardiac disease), severe psychiatric comorbid diseases (psychotic disorders, personality disorders, current trauma, acute suicide risk) or specific social constraints (distance from the clinic, in some circumstances ongoing pension procedures).

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Addresses

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Sources of Monetary or Material Support

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    • USC - Universitäts SchmerzCentrumUniversitätsklinikum Carl Gustav Carus
    • Mr.  Rainer  Sabatowski 
    • Fetcherstr. 74
    • 01307  Dresden
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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